Two articles in the Hastings Center Report, entitled “Ethical Oversight of Learning Health Care Systems” challenge the current ethical practices for protecting human volunteers in medical studies, according to a recent article on medicalnewstoday.com. The Hastings...
In November 2012, the FDA published a draft guidance, entitled “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is Needed,” which outlines recommendations for the...
Today, the IEDC released the below press release: INDIANAPOLIS (Jan. 29, 2013) – Pearl IRB, LLC d/b/a Pearl Pathways, a life sciences product development and regulatory consultant company, announced plans today to expand its operations here, creating up to 38 new jobs...
Although the elderly are often considered ineligible for clinical trials, experts in a recent article from Outsourcing-pharma.com are saying the age group “must be taken into consideration more often during research.” Clinical trials are intended to be...
According to an article on Outsourcing-Pharma.com, there is a dire need for strong, clear communication between entities when transferring IRB responsibilities. The article, entitled “Sponsor – CRO communication critical to IRB transfer; FDA,” states that all...
